VITROS Immunodiagnostic Products — Class II medical device recall Z-0060-2019
Ongoing recall by Ortho Clinical Diagnostics Inc, reported 2018-10-10, distributed nationwide. The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (Mic
| Recall number | Z-0060-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho Clinical Diagnostics Inc, Raritan, NJ, United States |
| Recall initiated | 2018-07-12 |
| Classified | 2018-10-03 |
| Reported by FDA | 2018-10-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BM, BR, CA, CL, CN, CO, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PL, PT, RU, SE, SG |
| Quantity | 1,790 |
| UPC / GTIN / UDI-DI | 10758750000111 |
Product
VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
Reason for recall
The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0060-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.